Amgen's KRAS G12C Inhibitor Sotorasib Granted FDA Breakthrough Therapy Designation for Advanced NSCLC; NDA Filing Planned by Year-End

Amgen Announces Today That the U.S. FDA Has Granted Its Investigational KRAS^G12CBreakthrough Therapy Designation for the Inhibitor Sotorasib in the Treatment of Locally Advanced or Metastatic KRAS-Mutant^G12Cpatients with mutated non-small cell lung cancer (NSCLC). These patients had previously received at least one prior systemic therapy. Meanwhile, Amgen announced that sotorasib has been included in the FDA’s Real-Time Oncology Review (RTOR) pilot program, which is expected to further expedite its review process. The company plans to submit a New Drug Application for sotorasib by the end of this year. The Breakthrough Therapy designation grants sotorasib eligibility for Priority Review and Accelerated Approval.

KRAS^G12CThe most common KRAS mutation in NSCLC. KRAS after failure of first-line therapy^G12CPatients with mutated NSCLC have limited treatment options, and current therapeutic outcomes are suboptimal. The objective response rate to second-line therapy in these patients is approximately 9–18%, with a median progression-free survival of around 4 months.

Sotorasib, developed by Amgen, is the first KRAS inhibitor to enter clinical trials.^G12CInhibitors are currently being investigated in extensive clinical programs. Within just over two years, the sotorasib clinical program has also established a robust clinical dataset, having been used to treat more than 600 patients across studies of 13 tumor types.

This breakthrough therapy designation is supported by the results of the Phase 2 CodeBreaK100 clinical trial. Patients with non-small cell lung cancer (NSCLC) enrolled in this trial experienced disease progression despite prior treatment with chemotherapy and/or immunotherapy. Data from the trial, published in The New England Journal of Medicine this September, showed that sotorasib achieved an objective response rate (ORR) of 32.2% and a disease control rate (DCR) of 88.1% in NSCLC patients, with a median progression-free survival of 6.3 months.

References:

[1] Amgen's Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation. Retrieved December 8, 2020, from https://www.prnewswire.com/news-releases/amgens-sotorasib-granted-breakthrough-therapy-designation-for-advanced-or-metastatic-non-small-cell-lung-cancer-patients-with-kras-g12c-mutation-301187803.html

[2] Hong et al., (2020). KRAS G12C Inhibition with Sotorasib in Advanced Solid Tumors. NEJM, DOI: 10.1056/NEJMoa1917239.

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